FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
72865–72888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 24, 2002
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K023349 · LPL
Contamac, Ltd.
Ophthalmic · 78d
Cleared Dec 24, 2002
CHEETAH I.V.D.S., MODEL 2002P
K023370 · DQK
Cheetah Medical, Inc.
Cardiovascular · 77d
Cleared Dec 24, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)
K023634 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Dec 24, 2002
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
K023667 · KRO
Plus Orthopedics
Orthopedic · 54d
Cleared Dec 24, 2002
QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3
K023731 · JJY
Consolidated Technology
Chemistry · 48d
Cleared Dec 24, 2002
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS...
K023784 · LBR
Hemagen Diagnostics, Inc.
Chemistry · 42d
Cleared Dec 24, 2002
AMMONIA ASSAY FOR THE ADVIA 1650
K023841 · JIF
Bayer Diagnostics Corp.
Immunology · 36d
Cleared Dec 24, 2002
SCOUT BOSS
K023961 · ITI
Burke, Inc.
Physical Medicine · 25d
Cleared Dec 24, 2002
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160
K023962 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 25d
Cleared Dec 24, 2002
FEMOSTOP FEMORAL COMPRESSION SYSTEM
K024107 · DXC
Radi Medical Systems AB
Cardiovascular · 11d
Cleared Dec 23, 2002
LTFS230
K021775 · LNS
Healthtronics, Inc.
Gastroenterology & Urology · 208d
Cleared Dec 23, 2002
AIM-V (R) MEDIUM, MODEL 087-0112
K022086 · NDS
Invitrogen Corporation
Gastroenterology & Urology · 179d
Cleared Dec 23, 2002
DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
K022500 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 147d
Cleared Dec 23, 2002
PAROS CRP
K022690 · DCN
Horiba, Ltd.
Immunology · 132d
Cleared Dec 23, 2002
AIA-PACK CA 19-9
K023239 · NIG
Tosoh Corp.
Immunology · 87d
Cleared Dec 23, 2002
ST AIA-PACK CA 19-9
K023240 · NIG
Tosoh Corp.
Immunology · 87d
Cleared Dec 23, 2002
AMALGA PACS
K023246 · LLZ
Global Care Solutions, S.A.
Radiology · 84d
Cleared Dec 23, 2002
CHAMPION 5000 PERIPHERAL VASCULAR COIL
K023247 · MOS
Usa Instruments, Inc.
Radiology · 84d
Cleared Dec 23, 2002
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269 · DCK
Instrumentation Laboratory CO
Chemistry · 83d
Cleared Dec 23, 2002
DISPOSABLE ASPIRATION NEEDLE NA-200H
K023272 · FCG
The Olympus Optical Co.
Gastroenterology & Urology · 83d
Cleared Dec 23, 2002
MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02
K023293 · IYE
Med-Tec,Inc.
Radiology · 82d
Cleared Dec 23, 2002
CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023322 · LLZ
Barco N.V.
Radiology · 80d
Cleared Dec 23, 2002
IMAGETILE
K023339 · LLZ
Barco N.V.
Radiology · 77d
Cleared Dec 23, 2002
CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023340 · LLZ
Barco N.V.
Radiology · 77d